System for treatment of anal incontinence

ABSTRACT

A method of treating anal incontinence in a patient comprises providing a sling having a central portion and first and second arms, creating a subcutaneous tunnel between a first buttock incision and a second buttock incision in the patient, mechanically widening the subcutaneous tunnel to create a pocket for the central portion of the sling, grasping the first arm of the sling and pulling the sling through the subcutaneous tunnel such that the central portion of the sling rests underneath the ano-rectum, inserting an introducer needle through a first thigh incision formed in the patient and advancing the introducer needle through the first buttock incision, pulling the first sling arm through the first thigh incision, inserting the introducer needle through a second thigh incision formed in the patient and advancing the introducer needle through the second buttock incision, and pulling the second sling arm through the second thigh incision.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.12/369,415, now U.S. Pat. No. 8,172,745, issued on May 8, 2012 filedFeb. 11, 2009, which claims benefit of U.S. Provisional Application No.61/027,702, filed on Feb. 11, 2008, and which is a continuation-in-partof U.S. application Ser. No. 11/765,761, filed Jun. 20, 2007, now U.S.Pat. No. 7,794,385, issued on Sep. 14, 2010, which claims benefit ofU.S. Provisional Application No. 60/868,850, filed Dec. 6, 2006, andwhich is a continuation-in-part of PCT Application No.PCT/US2005/046201, filed Dec. 20, 2005, which claims the benefit of U.S.Provisional Application No. 60/637,665, filed Dec. 20, 2004, and whichclaims the benefit of U.S. Provisional Application No. 60/673,878, filedApr. 22, 2005; the entireties of which are hereby incorporated byreference.

BACKGROUND OF THE INVENTION

Anal incontinence is a common problem that occurs in both men and women,though is certainly more prevalent in women after vaginal childbirth,presumably the result of trauma to pelvic floor muscles, supportingfascia and nerves. Fecal incontinence affects an estimated 7.6 percentof women between the ages of 30-90. The prevalence increases with age,affecting 3.6 percent of women between 30-39 and 15.2 percent of womenbetween 80-90. Several factors contribute to anal continence, includingthe resting tone of the external and internal anal sphincters, as wellas the position of the levator ani muscles, especially the puborectalismuscle, which forms a sling around the rectum and is responsible for theso-called “ano-rectal angle,” which keeps stool in the rectum untilvoluntary defecation relaxes the puborectalis muscle and straightens theangle, allowing stool to move towards the anus.

Defecation is often aided by expulsive abdominal forces. Analincontinence may occur as the result of several mechanisms, includingdirect damage to the internal or external anal sphincters (fromiatrogenic episiotomy or spontaneous lacerations during vaginaldelivery), or to the levator ani muscles. It may also result fromindirect injury of these muscles through denervation of the nerves thatsupply these muscles. Treatment of this problem has centered on pelvicfloor rehabilitation, dietary changes, or surgical correction. Surgeryhas been used to treat specific defects in the anal sphincters, such asexternal anal sphincteroplasty. Success rates of only 50% or less aregenerally reported for these procedures on long-term follow-up.

More recently, an artificial anal sphincter has been used to bypassthese muscles, though this surgery involves fairly extensive dissectionand requires the patient to depress a subcutaneous valve whichtemporarily deflates the sphincter cuff and allows voluntary defecation.This procedure is performed in very few centers in the U.S., and even inexperienced hands, complications occur frequently. Dynamicgraciloplasty, which involves mobilization and wrapping of the gracilismuscle around the ano-rectum is now another accepted procedure althoughit remains complex and requires extensive experience to obtain goodresults. More recently, sacral nerve stimulation has been used with somesuccess to treat fecal incontinence, though the mechanism of success inthese patients remains unclear, and may not be appropriate in women withobvious anatomic abnormalities, such as anal sphincter or levator muscledisruptions.

In addition, many women report other symptoms of bowel dysfunction, suchas constipation and incomplete bowel emptying. For some women, thesesymptoms are due to either an anterior rectocele (a hernia of the rectuminto the vaginal canal), or due to a defect in the levator ani muscles,which results in descent of the levator plate and/or perineum withabdominal straining. In addition, patients may be noted to have a defectin the posterior aspect of the rectum, or a posterior rectocele. Thereare very few treatment options for this condition, though retrorectallevatorplasty has been used in the past. In this procedure, an incisionis made between the anus and the coccyx and the levator muscles areexposed bilaterally. Sutures are then placed in the levator muscles toplicate them together in the midline.

Pelvic organ prolapse is a condition where organs, such as the uterus,the rectum, or the bladder, fall down or slip out of place within aperson's body. It is commonly used in reference to organs protrudingthrough a woman's vagina, but prolapse may occur within men as well. Ingeneral, the levator ani muscles provide the main support for pelvicorgans including, for example, the rectum, the vagina, and the urethra.In a person with a normal pelvis, the levator ani muscles keep thepelvic floor closed, thereby allowing the pelvic and abdominal organs torest on the levator ani muscles. This also significantly reduces thetension that would otherwise be placed on the fascia and ligaments thatsupport the pelvic organs. The posterior portion of the levator animuscles arise from the area of the tendinous arch. The anterior portionof the levator ani muscles arise from the superior pubic rami and fromthe anterior end of the obturator internus muscles. This portion formsthe pubococcygeus muscle and the puborectalis muscle. The pubococcygeusmuscle is a generally thick, U-shaped muscle through which the urethra,vagina, and rectum transverse. The pubococcygeus muscle supports thesestructures at rest, and helps to augment the endopelvic fascia duringcoughing or straining. The puborectalis muscle is structured to act as asling support for the rectum, and includes two ends that attach to theanterior side of the symphysis pubis. The levator ani muscle groupincludes an opening through which the vagina and urethra pass, which isreferred to as the urogenital hiatus. Similarly, the levator ani musclegroup includes an opening through which the rectum passes, which isreferred to as the rectal hiatus.

In a normal woman, the pelvic floor muscles support most of the weightof the pelvic organs, such as the vagina, uterus, bladder, and rectum.Additionally, the various pelvic fascia and ligaments stabilize thesestructures in position. When the natural anatomic relationships in thepelvis are disrupted, or if injuries occur, dysfunctions such as urinaryincontinence, fecal incontinence, or prolapse of the pelvic organs, mayoccur. For example, if one of the levator ani muscles is damaged, themuscle may be unable to adequately support the weight of the pelvicorgans. This will result in a disproportionate amount of the pelvicorgan weight being placed onto the pelvic ligaments, which aresignificantly weaker than the fibrous tissue of the ligaments thatconnect bones. In particular, the pelvic ligaments are more accuratelydescribed as thickening of the endopelvic fascia tissue, which iscomposed of collagen, smooth muscle, elastin, and fibrovascular bundles.These ligaments are not designed to carry the increased load resultingfrom problems in the pelvic floor. As a result, these ligaments mayeventually fail. The failure or damage to the pelvic floor ligaments maycause, for example, the bladder, rectum, or uterus to prolapse throughthe vagina. Similarly, expansion of or damage to the levator or rectalhiatus may result in the bladder, vagina, or rectum prolapsing throughthe hiatus.

As stated previously, pelvic prolapse conditions result from theweakness or damage to the normal pelvic-support systems. In general, themain categories of pelvic prolapse include cystocele, rectocele,enterocele, uterine prolapse, and vaginal vault prolapse. The mostcommon causes of these pelvic floor disorders in a female patientinclude child birth and removal of the uterus (hysterectomy). However,other contributing factors may include connective tissue defects,prolonged heavy physical labor, postmenopausal atrophy, neurogenicweakness of muscles, muscle weakness due to aging, and obesity.

A cystocele occurs when damage to the pubocervical fascia in the centralor lateral areas (or both) allows the bladder to protrude into thevagina. Simply defined, a cystocele is a protrusion of the bladder intothe vagina due to defects in pelvic support.

A rectocele is a bulge into the vagina caused by the rectum prolapsingthrough an attenuated rectovaginal septum. A rectocele is commonly aresult of childbirth or chronic constipation. During childbirth, therectovaginal septum and surrounding vaginal tissues are stretched anddisrupted, which may cause weakness and stretching in these tissues. Arectocele typically forms a pocket just above the anal sphincter wherestool may become trapped.

An enterocele is essentially a herniation of the small bowel into thevagina. Specifically, the peritoneal sac containing a portion of thesmall bowel extends into the rectovaginal space between the posteriorsurface of the vagina and the anterior surface of the rectum.

A uterine prolapse is the distention of the uterus and cervix outsidethe vagina. It is often associated with a rectocele, cystocele, orentrocele.

Finally, a vaginal vault prolapse is the distention of the vaginal apexafter hysterectomy outside the vagina. It is also often associated witha rectocele, cystocele, or entrocele.

What is needed is an improved system and method for the treatment ofanal incontinence and defecatory dysfunction, as well as pelvic organprolapse.

BRIEF SUMMARY OF THE INVENTION

The present disclosure describes systems and methods for treating analincontinence and other types of defecatory dysfunction, such as perinealdescent, constipation, incomplete bowel emptying, and rectal prolapse.The present disclosure also describes systems and methods for treatingpelvic organ prolapse and other pelvic floor disorders. Some disclosedsystems and methods particularly facilitate minimally-invasive treatmentof anal incontinence, defecatory dysfunction, and pelvic organ prolapse.

In accordance with one aspect of the present invention, a method oftreating anal incontinence in a patient is disclosed that comprises thesteps of providing a sling having a central portion and first and secondarms, creating a subcutaneous tunnel between a first buttock incisionand a second buttock incision in the patient, mechanically widening thesubcutaneous tunnel to create a pocket for the central portion of thesling, grasping the first arm of the sling and pulling the sling throughthe subcutaneous tunnel such that the central portion of the sling restsunderneath the ano-rectum, inserting an introducer needle through afirst thigh incision formed in the patient and advancing the introducerneedle through the first buttock incision, pulling the first sling armthrough the first thigh incision, inserting the introducer needlethrough a second thigh incision formed in the patient and advancing theintroducer needle through the second buttock incision, and pulling thesecond sling arm through the second thigh incision.

In accordance with another aspect of the present invention, a sling isdisclosed that comprises a central portion having a first end and asecond end, a first connector coupled to the first end of the centralportion, a first sling arm structured to be received by the firstconnector, a second connector coupled to the second end of the centralportion, and a second sling arm structured to be received by the secondconnector. The first and second connectors may include, for example,ring-shaped members having a plurality of tines that are structured toengage with the sling arms.

In accordance with yet another aspect of the present invention, a slingis disclosed that comprises a central portion having a first end, asecond end, a superior surface, and an inferior surface, a first slingarm extending from the first end of the central portion, a second slingaim extending from the second end of the central portion, and anadjustable device coupled to the inferior surface of the centralportion, the adjustable device including a housing and adjustment meanscoupled thereto, wherein the adjustable device is structured to adjust atension of the first and second sling arms.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 depicts the anatomy of the bony pelvis.

FIG. 2 depicts an exemplary placement of a needle device in the pelvis.

FIG. 3 illustrates one exemplary embodiment of a sling in accordancewith the present invention

FIGS. 4-5 depict steps in one exemplary placement method of the sling ofFIG. 3.

FIGS. 6-7 depict steps in another exemplary placement method of thesling of FIG. 3.

FIG. 8 depicts an exemplary final position of the sling of FIG. 3 withina patient.

FIGS. 9A-9D illustrate various embodiments of removable sheath membersstructured to cover at least a portion of a sling in order to promotepassage of the sling through tissue during surgical placement.

FIGS. 10-18 depict exemplary uses of various instruments to position asling or length of supporting material.

FIG. 19 is a diagram illustrating an alternative sling embodiment havinga center portion with a generally curved, saddle-like shape.

FIGS. 20-21 illustrate exemplary positioning of the sling of FIG. 19within a patient.

FIG. 22 depicts an alternative sling embodiment having four sling alms.

FIGS. 23A-23B are diagrams illustrating one exemplary positioning of thesling of FIG. 22 within a patient.

FIGS. 24-29 depict exemplary sling embodiments having fluid-filled sacs.

FIGS. 30-33 depict an exemplary use of a stylet having a loop.

FIGS. 34-35 depict an exemplary use of a stylet having a hook.

FIG. 36 depicts one exemplary embodiment of a hybrid sling in accordancewith the present invention.

FIGS. 37A-37C depict alternative embodiments of hybrid slings inaccordance with the present invention.

FIGS. 38A-38B illustrate another exemplary sling positioned within apatient that includes sling arms having serrations.

FIG. 39 depicts one exemplary sling embodiment having aims that includea plurality of tines.

FIGS. 40-42 illustrate one exemplary embodiment of a sling that includesrigid or semi-rigid elements coupled to a central portion thereof.

FIG. 43 illustrates another exemplary embodiment of a sling that alsoincludes rigid or semi-rigid elements coupled to a center portionthereof.

FIGS. 44A-44B demonstrate alternative sling embodiments illustrating theuse of “less elastic” sections of material in one or more areas of thesling.

FIG. 45 is a diagram illustrating an exemplary sling embodiment havingarms that are anchored to the inferior-medial portion of the ischiopubicrami with bone anchors.

FIG. 46 depicts the use of an exemplary device to measure the ano-rectalangle.

FIG. 47 generally depicts another exemplary method for treating analincontinence, defecatory dysfunction, or pelvic organ prolapse accordingto the present invention.

FIGS. 48A-48B depict an exemplary transfer device that can be used toreversibly connect to connectors attached to sling aims to allow fortransfer from one buttock incision to another buttock incision.

FIG. 49 demonstrates a mechanical device that can be used to tunnelbetween two buttock incisions and then spring open to dilate the path.

FIG. 50 demonstrates the tunneling device of FIG. 49 in place betweentwo buttock incisions.

FIG. 51 demonstrates a balloon device that can be used to tunnel betweentwo buttock incisions and then be inflated to dilate the path.

FIG. 52 illustrates one exemplary embodiment of an adjustable devicelocated at the center of a sling that has sutures that are loopedthrough sling arms, wherein the adjustable device is structured fortightening and loosening of the sling.

FIG. 53 illustrates another exemplary embodiment of an adjustable devicelocated at the center of the sling that has sutures that extend up to afixed device located on the sling arms.

FIG. 54 illustrates yet another exemplary embodiment of an adjustablesling that includes two adjustable devices located on opposing sides ofthe sling that have sutures that extend up to fixed devices on the slingaims.

FIG. 55 illustrates one exemplary fascial anchor that is placed on theobturator fascial membrane with the use of an introducer needle.

FIG. 56 illustrates the fascial anchor of FIG. 55 with a serrated mesharm passing through the anchor.

FIG. 57 demonstrates a transrectal manometry device that may be used todetermine the tension on a sling.

FIG. 58 illustrates an alternative sling embodiment that includes ananterior extension that encircles the anal sphincter in order to provideincreased anterior support.

FIG. 59 illustrates two slings placed in a patient, including atransobturator post-anal sling and another sling placed anterior to theanal sphincter in the perineal body, which passes back through theischiorectal fossa and out the buttocks.

FIG. 60 illustrates one exemplary embodiment of a larger levator slingplaced through the ischiorectal fossa that has transobturator meshstraps adjacent the obturator foramen as well as adjustable mesh strapsanchored into the sacrospinous ligament.

FIG. 61 is an enlarged view of an adjustable mesh strap of FIG. 60.

FIG. 62 illustrates another exemplary embodiment of a larger levatorsling passed through the ischiorectal fossa that has transobturator meshstraps as well as proximal lateral mesh straps that are passed throughthe sacrospinous ligament.

FIGS. 63-64 illustrate an alternative embodiment of a sling inaccordance with another aspect of the present invention, wherein acentral portion of the sling includes a pair of rings structured toreceive a corresponding pair of sling aims.

FIG. 65 is an enlarged view of one of the pair of rings illustrated inFIGS. 63-64.

FIG. 66 is a diagram illustrating one exemplary instrument that can beused to push the central portion of the sling of FIGS. 63-64 up on thesling arms in order to tighten the sling.

DETAILED DESCRIPTION OF THE INVENTION

The present disclosure provides a variety of systems and methods fortreating anal incontinence, defecatory dysfunction and pelvic organprolapse. The normal ano-rectal angle can be restored by inserting adisclosed device under the posterior rectum, which may be supported witha synthetic or natural material in a sling-like position behind the anusand/or rectum. A posterior supporting apparatus may provide partial orcomplete closure of the rectum and/or anus with the posterior supportingapparatus.

In one embodiment, a synthetic or natural sling material may be placedunder the rectum and may be supported by its aims, which may be extendedup in a sling-like fashion through the obturator foramen bilaterally, orretropubically to the suprapubic region. In another embodiment, thedevice placed posterior to the rectum may include one or more inflatableor fluid-filled sacs, which may or may not be adjusted post-operatively,by either changing the position or by altering the amount of fluidmaterial, for example saline or a hydrogel, within the sacs. “Fluid”should be understood to include gasses, liquids, and semisolid media(such as gels). In some embodiments, the central portion of the slingmay have a curved shape, such as a saddle shape, to help it conform tothe external contour of the anus, rectum, ano-rectal angle, and/orlevator ani muscles.

In one embodiment of a method of treating anal incontinence ordefecatory dysfunction, an incision may be made between the anus and thecoccyx and dissection performed, whereby the levator muscles and thelevator plate are exposed. A small nick may be made on the medial thighjust lateral to the ischiopubic ramus and an introducer needle may beplaced through the medial thigh incision, around the ischiopubic ramus,and be directed posteriorly into the ischiorectal fossa. The needle maythen be directed lateral to the levator muscles, optionally with theassistance of a surgeon palpating the instrument though the vagina. Theneedle may then be brought posterior to the rectum, exiting the incisionthat was made in the midline. Alternatively, the needle may be passedfrom the midline incision between the anus and coccyx to the medialthigh incision lateral to the ischiopubic ramis. In one embodiment, asuture may be threaded onto the eye of the needle, which in this casemay be placed from the medial thigh to the incision between the anus andthe coccyx, and may then be withdrawn through the tissue and held on themedial thigh. The procedure is repeated on the contralateral side. Asynthetic (i.e., polypropylene, polyester, etc.) mesh (such astension-free vaginal tape, TVT) or natural graft material may then beattached to each of the sutures coming from the midline incision, andthe mesh may then be brought up through the medial thigh incisions bypulling up on the sutures.

The mesh may have a covering plastic sheath, which can facilitatepassage through the tissues. The sheath may be removed when the sling isproperly adjusted.

In another embodiment, the needle that is passed through the tissue mayhave a hollow sleeve or tube over it (e.g., made of plastic, metal, orthe like), and after passage, the needle may be withdrawn through thetissue, leaving the hollow sleeve in place. A stylet (e.g., made ofplastic, metal, or the like) may then be then placed in the tube. Thestylet may have a connector, such as a hook or a loop, so that a lengthof supporting material, such as a synthetic mesh (e.g., made ofpolypropylene or the like) or a natural graft, may be attached to thestylet connector. Once this procedure is performed bilaterally, thesupporting material may be positioned under the rectum and the tensionon the arms of the sling may be adjusted. If the sleeves or tubes areutilized, the mesh can be adjusted before withdrawing the sleeves ortubes.

In another embodiment, two passes of the needles can be made on eachside, one approximately at the level of the medial superior portion ofthe obturator foramen, and the other several centimeters inferior andslightly more lateral (at the inferior portion of the obturatorforamen). This permits two lengths of supporting material (also called“mesh” but not necessarily limited to mesh) to be brought up on eachside. These mesh strips are attached to a central mesh that may beplaced under the rectum, which may be a pre-formed mesh, or may beconstructed by attaching the central mesh to the four mesh strips—two oneach side. The subrectal portion may be synthetic mesh, or may be madeof another material, such as an inflatable or fluid-filled polymer sac.The sub-rectal element provides support to the posterior anus and/orrectum, and creates an angle between the anus and rectum, which keepsstool in the rectum until voluntary defecation.

In another embodiment, after the needle passes through the tissue, andis withdrawn, leaving a hollow tube in place, a plastic or metal stylet,previously fixed to the mesh with or without a sheath, can be placed upfrom the sub-rectal incision to the medial thigh incision and can beheld. The mesh may then be brought up through the tubing by pulling onthe stylet from above. Once the sling end comes out from the tubing, thehollow tube can be removed, after the sling has been adjusted for propertensioning.

In another embodiment, the posterior aspect of the sub-rectal portionmay be attached to the coccyx by one of several methods, such as directsuturing or with bone anchors. Such attachment can help maintain theposition of the sub-rectal portion, which, in effect, restores thestructure and function of the levator plate. Alternatively, thesub-rectal portion may have an extension coming off its inferiorportion, which extends out and is fixed to the coccyx.

The fluid-filled sac under or adjacent to the rectum may have a port,such as a subcutaneous port, that may allow for fluid addition orremoval in the post-operative period. This port may facilitatepost-operative adjustment of the size and/or shape of the sac to providefor optimal results. The subcutaneous port may be placed directly underthe sac, in the perineal skin, or may be connected to the sac by meansof a connector tubing so that the port does not need to be located inthe perineum itself, but instead may be positioned in a number of areas,including, for example, the buttocks.

The needle may have a hook near the end, that can be covered duringinsertion, but that may be exposed after the needle has been placedthrough the tissue. The user implanting the device may operate a switchor other actuator, such as a spring-loaded mechanism, to expose thehook. The arm of the sling, or a pre-loaded suture on the sling-arm, maythen be placed on the hook and the needle withdrawn through the tissue.

In another embodiment, once the needle is placed through the tissue, thetip of the needle may be unscrewed off the end of the needle shaft. Theof the sling may have a device attached to each end that may screw ontothe needle shaft or otherwise fasten onto the needle shaft. The needlemay then be withdrawn, bringing the sling arm through the tissue.

A sheath covering the needle may remain in place in order to facilitatethe movement of the synthetic material through the tissue, which may beremoved once the tension on the sling is adjusted. The sheath may bedeformable, rather than rigid or semi-rigid, and may be flattened afterremoval of the needle, to accommodate the flat shape of the slingmaterial itself.

The needle could have a blunt metallic insert (to maintain the strengthof the needle) with a plastic covering sheath that has a sharp needletip configuration on the end. After the needle is placed through thetissue, the metallic blunt needle may be withdrawn, and the plasticneedle tip cut off. A suture retriever may then be placed anterogradethrough the hollow plastic tube in order to grasp a suture that has beenattached or pre-attached to the sling. The sling may be withdrawnthrough the plastic tube and the tube may be removed once the sling isadjusted.

In another embodiment, the needle tip may be made from two separatepieces that act as jaws that open to catch the mesh or suture attachedto the mesh, after the needle is passed through the tissue from themedial thigh to the incision posterior to the anus. This needle may beintroduced with a plastic outer covering, so that the sling material maybe drawn up through the tissue without catching on the surroundingstructures. Once in proper position, the surgeon may remove the plasticsheath, which would then allow for the synthetic mesh to become fixed inthe tissues.

A curved metal needle may be placed through the tissue from the medialthigh to the perineal incision. The end of the needle may be unscrewed,and the sling with attached plastic or metal piece may be screwed orsnapped onto or into the connector on the needle. The sling, possiblywith covering sheath, may then be withdrawn through the tissue and heldand the plastic sheath may be removed after the sling has been adjusted.

The shape of the sling may be a fixed width throughout its length.Alternatively, the central portion that is positioned under/behind therectum may be wider than the amts. The central portion may be curved tohelp it conform to the shape of the tissue it is supporting. The curvedshape may be a saddle shape, such as roughly a hyperbolic paraboloid orresembling a PRINGLES® brand potato crisp. The central portion may bepreformed with the curved shape.

The mesh may be continuous throughout the length of the sling, or mayhave a central portion that includes a fluid-filled sac that is affixedto the sling aims on the sides. Preferably, the synthetic mesh would becontinuous throughout its length in order to provide a backboard ofsupport under the rectum and under the fluid-filled sac, if thefluid-filled sac is employed.

The fluid sac may have a circular or elongated shape under the rectum,or may include several compartments that can be separately filled withseveral access ports, in order to change the occlusion of the rectum.The fluid filled sac may have the curved shapes as discussed above.

Wings may connect a sling central portion to the aims of the sling. Thewings may be made of mesh or other supporting material.

In another embodiment, the sling may be a hybrid of materials, comprisedof, for instance, a polypropylene mesh along the aims of the sling inorder to have self-attaching properties to the obturator fascia, and anatural xenograft material, such as porcine small intestinal submucosa,or an allograft, such as cadaveric fascia, located under and or lateralto the anus/rectum.

In another embodiment, the arms of the sling may include a syntheticmaterial such as silastic, polypropylene or other plastic, and may haveserrations or tines that increase the ability of the aims to grab on tothe obturator fascia as the aims are pulled through the tissue.

In another embodiment, the arms of the sling include sutures. There maybe several sets of sutures on each side, in order to prevent thesub-rectal portion of the sling from rolling up underneath theano-rectum.

In another embodiment, the anus of the sling may be attached to pelvicbone, such as the inferior-medial portion of the ischiopubic rami, orthe inferior portion of the pubis, with bone anchors, suture material,or other fixation devices.

In another embodiment, the material under and/or lateral to theano-rectum includes a synthetic material, such as silastic or otherplastic material, that may be flexible, to conform to the shape of thebowel.

In another embodiment, a number of synthetic or natural elements areattached to the mesh in a direction transverse to the length of thesling, such as perpendicular or substantially perpendicular to thelength of the sling. The elements may be semi-rigid and may be sopositioned in the mesh as to be located under or lateral to the bowelwhen the mesh is deployed, for the purpose of keeping the mesh fromrolling up underneath the ano-rectum. For example, the graft may have astiff or flexible bar incorporated into the graft, located on eitherside of the rectum, to prevent rolling of the graft material.Alternatively, one or more rigid or semi-rigid elements may be attachedto the sling in a direction generally parallel to the length of thesling.

In another embodiment, the sling may have additional straps attached tothe subrectal portion that penetrate posteriorly, such as on either sideof the coccyx, that may pass through the subcutaneous tissue and holdthe graft in position, to prevent rolling of the subrectal mesh.

In another embodiment, the synthetic material may be elastic, which maypermit stretching of the sling with abdominal straining, such as occurswith voluntary defecation.

In another technique, the sling may be passed through the levator animuscle, rather than behind the muscles.

In another embodiment, the system may include a device used to evaluatethe anorectal angle, for pre-operative diagnosis, intra-operativeadjustment, and/or post-operative evaluation. The device is sufficientlyflexible that it can be flexed to conform to the anorectal angle. Theamount of flexion may be measured, thereby establishing the shape of theano-rectal angle. In one embodiment, the device may be inserted into therectum, and a flexible joint of the device may be placed at the junctionbetween the anus and rectum. The device may then measure the anglecreated between the rectal and anal portions, and this angle may bedisplayed visually on the device, in one of a number of manners,including a dial or a digital display. The angle may also becommunicated to an external display for convenience. The device mayinclude a rotation or position sensitive transducer. This ano-rectalangle measurement device may be adapted so that it fits over theexaminer's gloved finger with a portion that fits over or on theexaminer's distal finger, and another portion that fits over or on theproximal finger. In this manner, when the examiner bends his or herfinger to determine the ano-rectal angle, the measured angle is recordedvisually on a display.

Various portions of the sling device may be coated, impregnated, orformed with one or more drugs to be eluted to an adjacent tissue. Forinstance, there is evidence in the literature that androgen treatmentmay increase the mass of the levator ani muscles. A drug eluding orimpregnated sling material (such as a mesh) may be used since the slingis abutting the levator ani muscles and may improve the mass andpossible function of the muscles.

Additionally, various portions of the device may be formed ofbiodegradable or bioabsorbable material.

According to another aspect of the present invention, an alternativemethod for treating anal incontinence, defecatory dysfunction, or pelvicorgan prolapse includes creating a subcutaneous tunnel between twobuttock incisions that are placed approximately halfway between thelevel of the anus and the coccyx, such as about 1.5 cm lateral to theanus. The tunnel may be widened mechanically to create a pocket, inwhich the sling belly or central portion may sit. The sling may bepulled through from one buttock incision to the other, and positioned sothat the central portion of the sling rests under the ano-rectum. Acurved introducer needle may then be placed through a small incision inthe patient's inner thigh, at the level of the external urethral meatusand just lateral to the descending ischiopubic ramus (which correspondsto the medial portion of the obturator membrane). The needle may beadvanced into the ischiorectal fossa, lateral to the levator ani musclesand brought through the lateral buttock incision. A connector attachedto the sling ami may then be irreversibly attached to the introducerneedle and the sling arm may be transferred through the thigh incision.The same procedure may be performed on the contralateral side. Tensionmay be adjusted on the sling, and the plastic sleeves may be removed,leaving the sling in place supporting the posterior ano-rectum. Finally,the sling arms may be cut at the level of the skin and the fourincisions may be closed in standard fashion with either sutures or glue.

Turning now to the figures, FIG. 1 is a diagram illustrating the anatomyof the bony pelvis, including the pubic symphysis 6, the ischiopubicramus 2, the ischial tuberosity 9, the coccyx 4, and the obturatorforamen 1. FIG. 1 also demonstrates the relationship of the levator animuscles (and, in particular, the puborectalis 8) to the urethra 5,vagina 7, and rectum 3.

FIG. 2 is a diagram outlining a first surgical procedure using a needle11 with a handle 10 attached thereto in order to tunnel between a medialthigh incision 12, through the obturator membrane, and into theischiorectal fossa. As illustrated in FIG. 2, a needle tip 14 eventuallyemerges through a vertical incision 13 between the rectum 3 and thecoccyx 4.

FIG. 3 illustrates one exemplary embodiment of a sling 16 in accordancewith the present invention. Sling 16 generally includes a pair of aims17 and a belly or central portion 20 disposed between the pair of arms17. Particularly, the wider central portion 20 disposed between thenarrower arms 17 may be structured such that it may sit under the rectum3 and distribute forces over a wide area. As illustrated in FIG. 3, boththe arms 17 and the central portion 20 of the sling 16 are formed from amesh material, although numerous other configurations are contemplatedas disclosed herein and as will be appreciated by those skilled in theart. Additionally, the central portion 20 of the sling 16 does not haveto be structured with a width that is greater than a width of the arms17.

As illustrated in FIG. 3, each of the arms 17 may have a suture loop 33extending therefrom. Although not necessary, suture loops 33 may assistthe surgeon in placement of the aims 17 by providing an element that maybe grasped by the needle 11.

FIGS. 4-5 depict steps in one exemplary placement method in accordancewith the present invention. As illustrated in FIG. 4, the needle 11 withthe attached handle 10 has been placed through a first medial thighincision 12, the obturator foramen, the ischio-rectal fossa, and outthrough the incision 13 between the rectum and the coccyx. A suture loop33 attached to the sling arm 17 may be grasped by the needle tip 14 inorder to transfer the sling to the thigh incision 12. FIG. 5 illustratesthe second pass of the needle on the contralateral side with the handle10 and needle 11 in place. The tip 14 may grasp the suture loop 33 onthe second aim 17 in order to pull the other arm of the sling up throughto the thigh incision. This allows the central portion 20 of the sling16 to rest under the ano-rectal area.

FIGS. 6-7 depict steps in another exemplary placement method. Asillustrated in FIG. 6, the needle 11 with the attached handle 10 hasbeen placed from the post-anal vertical incision 13 up through theischiorectal fossa, through the obturator foramen, and out through thethigh incision, and has transferred a suture attached to the sling 16 tothe thigh region. This allows the sling to be brought through thetissues up to the region of the thigh. FIG. 7 illustrates the right sideof the sling 16 in place and the needle 11 with attached handle 10transferring a suture attached to the left side of the sling arm 17 ofthe sling 16 up through the left side. The suture is being held by theneedle tip 14.

FIG. 8 is a diagram illustrating a final position of the sling 16 underthe anus and/or rectum. As shown in FIG. 8, the central portion of thesling is disposed between the anus and the coccyx, and the sling armsextend up through the medial portion of the obturator membrane 15.

FIG. 9A-9D illustrate various embodiments of removable sheath members 31structured to cover at least a portion of a sling, such as sling 16, inorder to promote passage of the sling through the tissues during thesurgical placement. Particularly, FIG. 9A is a first exemplaryembodiment of a sheath 31A that includes a first elongated sleeve member37A and a second elongated sleeve member 38A. As illustrated in FIG. 9A,elongated sleeve members 37A and 38A are each structured to receive oneof the arms of the sling therein. Next, FIG. 9B is a second exemplaryembodiment of a sheath 31B that also includes a first elongated sleevemember 37B and a second elongated sleeve member 38B. However, unlikesheath 31A, the first and second elongated sleeve members 37B and 38B ofsheath 31B are each structured to receive a part of the central portionof the sling. Furthermore, the first and second elongated sleeve members37B and 38B are structured such that their ends abut one another tocreate a seam near the center of the sling. The ends of the first andsecond elongated sleeve members 37B and 38B may be joined using anysuitable connection method, such as within an adhesive. In anotherembodiment, there is a “score” line between the first and secondelongated sleeve members 37B and 38B. Alternatively, the ends are notjoined, but are rather freely positioned adjacent one another. Movingon, FIG. 9C is a third exemplary embodiment of a sheath 31C thatincludes a first elongated sleeve member 37C and a second elongatedsleeve member 38C that are each structured to receive part of thecentral portion of the sling. Unlike the first and second elongatedsleeve members 37B and 38B of sheath 31B, the first and second sleevemembers 37C and 38C overlap one another as shown in FIG. 9C. Finally,FIG. 9D is a fourth embodiment of a sheath 31D that includes a firstelongated sleeve member 37D and a second elongated sleeve member 38Dthat are each structured to receive a part of the central portion of thesling. As will be appreciated by those skilled in the art, sheath 31D issimilar to sheath 31B previously described. However, the first andsecond elongated elements 37D and 38D of sheath 31D have a perforatedconnection.

FIGS. 10-12 demonstrate the use of an alternative needle introducer 27that may be placed, for example, from the medial thigh to the incisionbeneath the rectum as previously described. Once through the tissue, ajaw element of the needle introducer 27 opens in the middle, whichreveals a grasping instrument 28 that can hold on to a suture, such assuture 33 of sling arm 17. As illustrated in FIG. 13, the sling aim 17may have a plastic sheath 31 positioned thereon. The sling arm 17 maythen be brought through the tissue, with or without the use of an outertube 26 through which the grasping instrument 28 had been placed duringthe needle insertion process.

FIGS. 13-15 demonstrate the use of another alternative needle introducer32 that, after insertion through the tissue, can be advanced beyond anouter tube 26, with or without a spring-mechanism to deploy the needle.When the needle introducer 32 is advance, a notch 30 may be revealedupon which the suture loop 33 (previously attached to the mesh) can beplaced. The sling arm 17 may then be brought up through the tissues tothe medial thigh as previously described.

FIGS. 16-18 demonstrate the use of yet another alternative needleintroducer 34 that, after insertion through the tissue, may be separatedfrom a shaft 35 of the needle by unscrewing the needle tip. The slingmay be designed with a male-connector screw 36 that attaches to thestraight needle shaft 35 prior to withdrawing the needle shaft 35, whichin turn draws the mesh sling arm 17 up through the tissue.

Now that one exemplary embodiment of a sling has been described, alongwith a method of placing the sling and devices for assisting in suchplacement, several alternative sling embodiments will be described.Particularly, FIG. 19 is a diagram illustrating a sling 16A having acenter portion 20A (arms not shown) with a generally curved, saddle-likeshape. As will be appreciated by those skilled in the art, the saddleshape may facilitate making good contact with the anatomy to besupported. FIGS. 20-21 illustrate exemplary positioning of the sling 20Ain accordance with the present invention. As shown in FIGS. 20-21, onecurve of the saddle allows the sling to arc between the obturatorregions, while the other curve can complement the ano-rectal angle.

FIG. 22 is a diagram illustrating sling 16B, which is a secondalternative sling embodiment in accordance with the present invention.As shown in FIG. 22, sling 16B includes a center portion 20B with fourattached arms, namely a first pair or arms 18 and a second pair of anus19. The aims 18 may be structured to be passed from the medial superiorportion of the obturator membrane, and the arms 19 may be structured tobe passed through the inferior portion of the obturator membrane.

FIG. 23A is a diagram illustrating one exemplary positioning of thesling 16B in accordance with the present invention. Particularly, FIG.23A demonstrates the use of two pairs of synthetic mesh straps placedthrough the obturator membrane, the first pair 18 more distal and placednear the superior-medial aspect of the obturator foramen, and the secondpair 19 placed near the inferior portion of the obturator foramen.

FIG. 23B is a diagram illustrating another exemplary positioning of thesling 16B in accordance with the present invention. Particularly, FIG.23B demonstrates the positioning of one of the pairs of arms such thatthey are secured in place by passage into subcutaneous tissue in orderto prevent rolling of the sling. The pair or arms may be directedposteriorly, on either side of the coccyx, in order to keep thesubrectal portion flat.

FIGS. 24-29 illustrate various sling embodiments having fluid-filledsacs coupled thereto. FIG. 24 is a diagram illustrating sling 16C, whichis a third alternative sling embodiment in accordance with the presentinvention. Particularly, FIG. 24 illustrates a superior view of thesling 16C having a fluid-filled sac 23 on the superior side of thecentral portion 20C of the sling. Although the sling 16C of FIG. 24illustrates two pairs of arms extending from each end of the centralportion 20C, those skilled in the art will appreciate that the use offluid-filled sacs is not dependent upon the number of sling aims.Therefore, slings having any number of aims may include a fluid-filledsac without departing from the intended scope of the present invention.

FIG. 25 shows a lateral orientation of the pelvis and the sling 16C withthe pubic symphysis 21, the bladder 22, the uterus 25, and theischiorectal fossa 24 with two synthetic straps (i.e., first pair 18 andsecond pair 19) on each side. As illustrated in FIG. 25, thefluid-filled sac 23 is positioned in a sub-rectal location.

FIG. 26 is a diagram similar to FIG. 25 showing a lateral orientation ofthe pelvis with the sling 16C in place. However, as illustrated in FIG.26, sling 16C further includes an extension 26 of the sub-rectal elementattached to the coccyx. As will be appreciated by those skilled in theart, the extension 26 may be attached to the coccyx with numerouselements including, but not limited to, sutures, bone anchors, or othersuitable methods of affixing synthetic material to the coccyx.

FIG. 27 is a diagram illustrating sling 16D, which is a fourthalternative sling embodiment in accordance with the present inventionthat also includes a central portion 20D with an inflatable,fluid-filled sac 47. As shown in FIG. 27, connector tubing 48 isattached to the fluid-filled sac 47 and can be placed under the buttocksor other location within the reach of the tubing. Additionally, thefluid-filled sac 47 has a port 39 at the end that can be used forfilling or reducing the amount of fluid that is contained within the sac47.

FIG. 28 is a diagram illustrating an inferior view of a sling 16E, whichis a fifth alternative sling embodiment in accordance with the presentinvention. The sling 16E includes a fluid-filled sac 49 having a port 40accessible through an aperture at the bottom of the central portion 20Eof the sling. As will be appreciated by those skilled in the art, theport 40 may be accessed subcutaneously in order to either add more fluidor remove fluid.

FIG. 29 is a diagram illustrating a sling 16F positioned within apatient. The sling 16F is another alternative embodiment of a sling inaccordance with the present invention and generally includes a firstfluid-filled sac 56 superior to the central portion 20F of the sling,along with a pair of inflatable sacs 57 positioned medial to the aims17F of the sling. It follows that fluid-filled sacs may be positionedadjacent areas other than the central portion of the sling withoutdeparting from the intended scope of the present invention.

As will be appreciated by those skilled in the art based on theforegoing, the fluid filled sacs of the present invention may be usedfor either intra or post operative sling adjustment. Adjustment may bemade by, for example, a connector tube having a port attached thereto,or via a subcutaneous access port that controls one or more of thefluid-filled sacs. As previously discussed, “fluid” should be understoodto include gasses, liquids, and semisolid media (such as gels). Forexample, the fluid-filled sacs may be structured in the form ofinflatable balloon elements that may be filled with air or other gasses.

FIGS. 30-33 exhibit an exemplary use of a loop stylet during theplacement of a sling in accordance with the present invention. As shownin FIGS. 30-33, stylet 41 may be advanced through a tube 42 positionedwithin the patient along the desired path of a sling arm. A length ofsling material 43 may be threaded through a loop on an end of the stylet41 so that the material catches in the loop. The stylet may then bewithdrawn back through the tube 42 to bring the end of the slingmaterial 43 to the desired position.

Alternatively, FIGS. 34-35 show an exemplary use of a hook stylet 44during the placement of a sling in accordance with the presentinvention. As shown in FIGS. 34-35, a piece of sling material 45 may bestabbed onto a sharp tip of the hook 44. The hook 44 may then bewithdrawn through a tube, such as tube 42 in FIGS. 30-33, to bring theend of the sling material 45 to the desired location.

FIG. 36 is a diagram illustrating a hybrid sling 16G in accordance withthe present invention. Particularly, the hybrid sling 16G may becomprised of, for instance, synthetic mesh arms 17G attached to anatural material forming the center portion 20G placed under and/orlateral to the ano-rectum.

Alternative hybrid sling configurations are illustrated in FIGS.37A-37C. Particularly, FIG. 37A is a cross-sectional view of the centerportion 20G of sling 16G having a natural graft 58 positioned on asuperior surface of the synthetic sling. FIG. 37B is a cross-sectionalview of the center portion 20G of the sling 16G having a natural graft59 positioned on an inferior surface of the synthetic sling. Finally,FIG. 37C is a combination of the slings of FIGS. 37A and 37B thatincludes natural grafts 58 and 59 positioned on both superior andinferior surfaces of the synthetic sling, respectively. Although notshown, other alternative sling embodiments may include a natural graftthat is attached to one or both of the sling arms in addition to, orinstead of, the central portion of the sling. As will be appreciated bythose skilled in the art, attaching a natural graft to the centralportion and/or the aims of a sling may reduce the risk of erosion of thesling into either the rectum or the overlying skin.

FIGS. 38A-38B illustrate another exemplary sling 16H positioned withinthe patient that includes sling arms 17H made of a non-mesh, syntheticmaterial with serrations on each arm that maintain the sling in positionafter adjustment by the surgeon. Suitable synthetic materials mayinclude, but are not limited to, silastic, polypropylene, or othersuitable plastics.

FIG. 39 illustrates an alternative sling 161 similar to the sling 16H ofFIGS. 38A-38B, but instead including a plurality of tines rather thanserrations on the arms 171. However, as will be appreciated by thoseskilled in the art, the tines may serve the similar function ofmaintaining the sling in position by grasping onto tissue.

FIGS. 40-42 illustrate one exemplary embodiment of a sling 16J thatincludes rigid or semi-rigid elements 46 coupled to the central portion20J of the sling. The elements 46 may be attached to the sling 16J inorder to keep the sling from rolling under the ano-rectal portion. Aswill be appreciated by those skilled in the art, the elements 46 maycomprise synthetic or natural elements that are attached to the mesh ina direction transverse to the length of the sling, such as perpendicularor substantially perpendicular to the length of the sling. The elements46 may be semi-rigid and may be so positioned in the mesh as to belocated under or lateral to the bowel when the mesh is deployed, for thepurpose of keeping the mesh from rolling up underneath the ano-rectum.For example, the elements 46 may comprise stiff or flexible bars coupledto the sling such that they are located on either side of the rectum,and may be structured to prevent rolling of the sling material.

FIG. 43 illustrates a sling 16K that also includes rigid or semi-rigidelements coupled to the center portion 20K of the sling. Particularly,sling 16K includes a plurality of struts 70 adjacent outer edgesthereof. The struts 70 may be fixated from any suitable biocompatiblematerial, such as a plastic, and may be structured to be folded inwardfor passage into an area beneath the ano-rectum. Once the centralportion 20K of the sling 16K is positioned at the desired locationwithin the patient, the folded central portion of the sling may “spring”open into position due to the presence of the struts 70, therebyallowing the central portion 20K of the sling 16K to lie flat under theano-rectum.

FIGS. 44A-44B demonstrate alternative sling embodiments illustrating theuse of “less elastic” sections of material in one or more areas of thesling. Particularly, FIG. 44A is a diagram illustrating a mesh sling 16Lwith a strip of material 72 that runs substantially the entire length ofthe sling, wherein the mesh portion of the sling has an elasticity thatis greater than the strip of material 72 extending along the sling. Inone exemplary embodiment, the less elastic material may be apolypropylene ribbon material disposed within or extending along anouter surface of the sling 16L, although any suitable material having anelasticity less than that of the sling material may be used withoutdeparting from the intended scope of the present invention. Similarly,FIG. 44B is a diagram illustrating a mesh sling 16M with a pair ofmaterial strips 74 running substantially along the entire length of thesling arms 17M, but not within the central portion 20M of the sling.Once again the material strips 74 may be any suitable material having anelasticity less than that of the sling material. As will be appreciatedby those skilled in the art, adding a stiffer material to the mesh aimsand/or central portion of the sling may increase the ability to applygreater tension on the sling, if necessary.

FIG. 45 is a diagram illustrating a sling 16N positioned within thepatient and having sling arms 17N that extend to the inferior-medialportion of the ischiopubic rami and are anchored thereto with boneanchors 75 in order to hold the sling into position.

FIG. 46 depicts a device attached to the examiner's finger used tomeasure the angle between the rectum 3 and anus. The vagina 7 restsanterior to the anus and rectum, and the coccyx 4 is located posteriorto the rectum. A proximal ring 54 is placed on the proximal phalanx 51and the distal ring 55 is placed on the distal phalanx 50 and these areconnected by a joint 53. The angle made between the anus and rectum ismeasured and displayed on a visual scale 52.

In one exemplary embodiment, a method to treat anal incontinence and/ordefecatory dysfunction in a male or female may include:

placing an implant that passes under the anus and/or rectum and may passunder, over, or through the levator ani muscles;

placing one of the ends of the implant through the obturator foramen andthrough an incision made in the medial thigh on the same side of thepatient; and

providing an elongate instrument that is used to transfer one end of theimplant from the post-anal incision to a medial thigh incision, and thentransferring the other end of the implant from the post-anal incision tothe other medial thigh incision; or

providing an elongate instrument that is used to transfer one end of theimplant from a medial thigh incision to the post-anal incision, and thentransferring the other end of the implant from the other medial thighincision to the post-anal incision.

In another exemplary embodiment, a method of treating anal incontinenceand/or defecatory dysfunction in a male or female patient may include:

creating an incision between the anus and the coccyx (vertical orhorizontal);

creating an incision in the medial portion of each thigh;

providing an elongate instrument and an elongate implant for treatingthe condition;

passing one of the ends of the instrument between the post-analincision, through an obturator foramen on one side of the patient, andthe incision on the respective medial thigh;

associating the implant with the instrument;

using the instrument to pass the implant through the tissue between thepostanal incision and one thigh incision such that the implant extendsbetween the postanal incision, through the one obturator foramen, andone of the thigh incisions;

passing one of the ends of the same or another instrument between thepostanal incision, through the other obturator foramen, and the otherthigh incision; and

using the instrument to extend the implant between the post-analincision, through the other obturator foramen, to the other thighincision such that the implant then extends from one thigh incision tothe other thigh incision, through both obturator foramen and under thepatient's rectum and/or anus (below or above the level of the levatorani muscles).

Various embodiments disclosed herein can be combined with one another toprovide additional embodiments that include multiple features.

In another aspect of the present invention, the various slings andinsertion needles described above in reference to the treatment of analincontinence, defecatory dysfunction, or pelvic organ prolapse may beused in conjunction with another method for treating these conditions.In particular, FIG. 47 generally depicts one exemplary method fortreating anal incontinence, defecatory dysfunction, or pelvic organprolapse according to the present invention. The method begins at step 1where a physician marks the location of four incisions on a patient'spelvic region. In particular, the physician marks two posterior buttockincisions 60A and 60B and two thigh incisions 62A and 62B. The posteriorincisions 60A and 60B may be located about 1.5 cm lateral and about 3 cmposterior to the mid-anus (midway between the anus and the coccyx). Thetwo thigh incisions 62A and 62B may be, for example, at the level of theurethra along the descending pubic ramus.

The method continues at step 2 where the physician may inject a localanesthetic along a track from each thigh incision to the correspondingpost-anal incision on the ipsilateral side, and between the twopost-anal incisions. Then, in step 3, the physician uses a scalpel tomake the two posterior incisions 60A and 60B, which may be approximately1.5 cm in length. Next, in step 4, a small curved Kelly clamp or similarinstrument may be used to tunnel subcutaneously between the twoposterior incisions 60A and 60B to create a space between the incisions,posterior to the anus. The physician may place a finger in the rectum toassist in guiding the clamp during the tunneling process. The methodcontinues at step 5 where the physician inserts the clamp into posteriorincision 60B and through posterior incision 60A, grasping an end portionof a sling aim or a connector on the sling. Thereafter, the physicianpulls the sling through both incisions 60A and 60B until the centralportion of the sling lies beneath the ano-rectum.

Then, in step 6, the physician makes a small stab incision over a firstone of the thigh incision marks to create thigh incision 62A. Aninsertion needle (such as, for example, needle 11) is then insertedthrough thigh incision 62A in step 7 until it perforates the obturatormembrane. The needle is tracked around the ischiopubic ramus with thehandle portion of the needle generally parallel to the pelvic floor. Thephysician may use a finger to track the path of the needle down next tothe vagina. Next, in step 8, the physician moves his finger to posteriorincision 60A to track the needle out of the incision. The procedurecontinues at step 9 where the physician attaches the needle to theconnector on the end of the sling arm protruding outward from posteriorincision 60A and withdraws the needle back through the tissue and outthrough thigh incision 62A, pulling the sling arm to the desiredlocation.

Next, in step 10, the physician makes a small stab incision over thesecond thigh incision mark to create thigh incision 62B. The insertionneedle is then inserted through thigh incision 62B in step 11 until itperforates the obturator membrane. The needle is again tracked aroundthe ischiopubic ramus with the handle portion of the needle generallyparallel to the pelvic floor. Thereafter, in step 12, the physicianmoves his finger to posterior incision 60B to track the needle out ofthe incision. The procedure continues at step 13 where the physicianattaches the needle to the connector on the end of the sling armprotruding outward from posterior incision 60B and withdraws the needleback through the tissue and out through thigh incision 62B, pulling thesling arm to the desired location. Once the physician has grasped andpulled both of the sling aims through the corresponding thigh incisions62A and 62B, posterior incisions 60A and 60B may then be irrigated withan antibiotic solution and sutured in step 14.

Next, with a finger inserted into the rectum, the physician adjusts thesling arms in step 15 by grasping the excess portions of the aimsprotruding from thigh incisions 62A and 62B and pulling upward on bothaims until gentle tension is palpable through the rectum. Then, keepinga finger in the rectum, the physician cuts the sling aims (as well asthe sheath, if present) from the insertion needles and the sheaths areremoved, leaving the sling mesh in place. The sling arms are then cutclose to the patient's skin such that any excess portions of the slingaims protruding outward from the thigh incisions 62A and 62B areremoved. The thigh incisions 62A and 62B are then irrigated with anantibiotic solution and subsequently sutured in step 16, therebycompleting the sling implantation procedure. The sling, which may beconstructed as a mesh formed from many materials such as, for example,polypropylene, adheres to internal body tissue without the need foradditional sutures or attachment means.

One skilled in the art will appreciate that the procedure describedabove is merely one example of an alternative method for treating analincontinence, defecatory dysfunction, or pelvic organ prolapse accordingto the present invention. Thus, the steps described above may bemodified or re-ordered without departing from the intended scope of thepresent invention. Furthermore, although the method was described withreference to the treatment of pelvic organ prolapse in a female patient,those skilled in the art will appreciate that a similar method may beused to treat pelvic organ prolapse in a male patient as well. Inaddition, insertion needles and slings other than those shown anddescribed above in reference to FIGS. 2-46 may be used along with themethod of the present invention. To that end, additional devices andsling features that may be especially useful in the alternative methoddepicted in FIG. 47 will be described below.

When grasping one of the arms of a sling with a clamp or similar deviceand pulling it through the subcutaneous tunnel from one buttock incisionto the other buttock incision, the clamp may occasionally lose its gripon the sling arm. As a result, the physician must find the end of thesling aim and try to re-clamp the arm before continuing the procedure.In order to eliminate this type of scenario, sling arms may be designedwith a connector that may be reversibly attached to a transfer device toallow for improved transfer from one buttock incision to the other. Thistransfer device could be reversibly attached to the connector via anysuitable means including, but not limited to, extendable tines, wings,or an inflatable balloon, which would allow the device to release theconnector once the transfer from one buttock incision to the otherbuttock incision on the opposite side is complete. Control of theconnecting means on the transfer device may be accomplished with anysuitable actuator including, but not limited to, a push-button typeactuator or the like.

FIGS. 48A-48B depict the use of one exemplary transfer device 76 inaccordance with the present invention. Particularly, FIG. 48Aillustrates a portion of a sling arm 77 having a connector 78 extendingfrom an end thereof. The transfer device 76 generally includes anelongate body 79 and a tip 80 structured for insertion within anaperture 81 in a distal end of the connector 78. Upon insertion into theaperture 81, one or more wings 82 may extend from the elongate body 79of the transfer device 76 as illustrated in FIG. 48B. In this extendedposition within aperture 81, the connector 78 is reversibly coupled tothe transfer device 76 and the sling arm 77 may be pulled through thetunnel from one buttock incision to the other buttock incision. Once thesling 77 has been pulled through the tunnel, the wings 82 may be movedback to a retracted position thereby releasing the connector 78 from thetransfer device 76.

Those skilled in the art will appreciate that transfer device 76 ispresented merely for purposes of example and not limitation. Thus,numerous other types and styles of transfer devices may be used withoutdeparting from the intended scope of the present invention.

As will be appreciated by those skilled in the art, transferring of thesling from the first incision 60A to the second incision 60B (or viceversa) may be improved with the addition of a plastic sheath that coversthe arms and/or central portion of the sling body. Exemplary sheathswere previously illustrated in FIGS. 9A-9D. However, any suitable sheathembodiment may be used without departing from the intended scope of thepresent invention.

In order to further assist the surgeon in transferring a sling armbetween the first incision 60A and the second incision 60B, a tunnelingdevice may be use to widen the path between the two incisions. Wideningthe path may also help the sling lie flat under the ano-rectum. FIGS.49-51 illustrate various exemplary embodiments of tunneling devices thatmay be used to widen the path between the incisions 60A and 60B inaccordance with the present invention.

Particularly, FIG. 49 is diagram illustrating one exemplary embodimentof a mechanical tunneling device 86 that may be used to tunnel betweenthe two buttock incisions 60A and 60B. As will be appreciated by thoseskilled in the art, tunneling device 86 may be inserted through one ofthe first or second incisions 60A or 60B such that it is centeredbeneath the ano-rectum. During insertion, tunneling device 86 is in anarrow configuration with a first spring portion 87A and a second springportion 87B in a collapsed state. Then, once the tunneling device 86 iscentered beneath the ano-rectum, the first and second spring portions87A and 87B are structured to “spring” open as illustrated by the arrowsin FIG. 49 in order to dilate the path between the first and secondincisions 60A and 60B.

FIG. 50 is a diagram illustrating the mechanical tunneling device 86 ofFIG. 49 in place between the two buttock incisions 60A and 60B. As willbe appreciated by those skilled in the art, the mechanical tunnelingdevice 86 may further include “fins” that are structured to gently cutthrough the subcutaneous tissue to create an open tunnel for the sling.

FIG. 51 illustrates one exemplary alternative embodiment of a mechanicaltunneling device 88 that may be used to tunnel between the two buttockincisions 60A and 60B. Particularly, the mechanical tunneling device 88includes a balloon 89 structured to be inflated in order to dilate thepath between the incisions. As will be appreciated by those skilled inthe art, and similar to the embodiments of the fluid-filled sacspreviously described with reference to FIGS. 24-29, balloon 89 may befilled with any suitable fluid without departing from the intended scopeof the present invention. Again, “fluid” should be understood to includegasses, liquids, and semisolid media (such as gels). Additionally, theballoon 89 may have a port operably coupled thereto for adding orremoving fluid. The port may be coupled to a tube extending from theballoon 89, which may in turn be disposed within the main body of themechanical tunneling device 88 so that it is accessible outside of oneof the incisions.

In accordance with another aspect of the present invention, there may bea device located on the inferior surface of the belly or central portionof the sling that may be adjusted post-operatively in order to adjustthe position of the sling after implantation in the patient. Exemplarydevices are illustrated in FIGS. 52-54. Particularly, FIG. 52 a firstexemplary embodiment of an adjustable device 90 positioned on a sling 91having a first aim 92A, a second arm 92B, and a belly or central portion93 disposed between the first and second arms 92A and 92B. Asillustrated in FIG. 52, the adjustable device 90 includes a housing 94,a first suture 95A, and a second suture 95B. The first suture 95Aextends out of a first end of the housing 94 and up along the firstsling arm 92A where it is looped therethrough to couple the first suture95A to the first sling arm 92A. Similarly, the second suture 95B extendsout of a second end of the housing 94 and up along the second sling arm92B where it is looped therethrough to couple the second suture 95B tothe second sling arm 92B. Rather than being looped through the slingaims, the first and second sutures 95A and 95B may be coupled to therespective sling aims via any suitable connection means, such as bytying the sutures to the sling arms or adhering the sutures to the slingarms with an adhesive.

As further illustrated in FIG. 52, the housing 94 of the adjustabledevice 90 includes an adjustment means 96 for adjusting the position andlength of the sutures 95A and 95B. As will be appreciated by thoseskilled in the art, making adjustments with adjustment means 96functions to either draw the first and second sutures 95A and 95B intothe housing 94 in order to tighten the sling 91, or to allow the firstand second sutures 95A and 95B to be “let out” from the housing 94 inorder to loosen the sling 91. For instance, rotating the adjustmentmeans 96 in a first direction may cause a tightening of the sling 91,while rotating the adjustment means 96 in a second, opposite directionmay cause a loosening of the sling 91.

As will be appreciated by those skilled in the art, any suitableinterface between the first and second sutures 95A and 95B and theadjustment means 96 may be used that allows both tightening andloosening of a sling. In one exemplary embodiment, the first and secondsutures 95A and 95B are operably coupled to a spool which is controlledby rotational movement of the adjustment means 96. Furthermore, firstand second sutures 95A and 95B may be coupled to the same or differentspools. Numerous other embodiments are also contemplated and within theintended scope of the present invention.

FIG. 53 illustrates a second exemplary embodiment of an adjustabledevice 100 positioned on the sling 91 of FIG. 52. Adjustable device 100is similar to adjustable device 90 of FIG. 52, and includes a housing104, a first suture 105A, a second suture 105B, and an adjustment means106. However, rather than being looped through the first sling arm 92A,the first suture 105A is instead coupled to a first sling arm connectingmember 107A that is attached to the first sling arm 92A. Similarly,rather than being looped through the second sling arm 92B, the secondsuture 105B is instead coupled to a second sling arm connecting member107B.

The first and second sling arm connecting members 107A and 107B may beattached to their respective sling arms in any suitable manner as willbe appreciated by those skilled in the art. Furthermore, the first andsecond sling aim connecting members 107A and 107B may include a surfaceupon which their respective sutures may slide as the sling is tightenedor loosened. Alternatively, the first and second sling ami connectingmembers 107A and 107B may include a pulley or the like.

FIG. 54 illustrates a third exemplary embodiment wherein first andsecond adjustable devices 110A and 110B are positioned on opposite endsof the sling 91. The first adjustable device 110A includes a housing114A, a first suture 115A, and an adjustment means 116A. The firstsuture 15A is coupled to a first sling arm connecting member 117A thatis attached to the first sling aim 92A. Similarly, the second adjustabledevice 110B includes a housing 114B, a first suture 115B, and anadjustment means 116B. The second suture 115B is coupled to a secondsling arm connecting member 117B that is attached to the second slingaim 92B. As will be appreciated by those skilled in the art, first andsecond adjustable devices 110A and 110B operate similar to adjustabledevice 100 previously described. However, having separate adjustabledevices associated with each sling ami allows for independent tighteningand loosening of the slings arms, which may be desirable under certaincircumstances.

During surgical placement of a sling, rather than having to pull a slingarm through a thigh incision and cut the sling arm close to thepatient's skin such that any excess portion of the sling arm protrudingoutward from the thigh incision is removed as previously described, ananchoring device may instead be positioned on the obturator membranethat is structured to anchor the sling aim on the obturator membrane.Particularly, FIG. 55 illustrates a fascial anchor 120 that may beplaced on the obturator fascial membrane 121 between the pubis 122 andthe ischium 123. Although the fascial anchor 120 may be placed on theobturator membrane with any suitable insertion means, one exemplaryinsertion means may be an introducer needle 126.

Once the fascial anchor 120 has been attached to the obturator membrane121, a sling arm may be inserted through the anchor 120 in order tosecure the sling aim to the anchor. The fascial anchor 120 may be eithera unidirectional or a bidirectional device that grips the sling aim,which once again may be fanned from any suitable material including amesh material, or alternatively solid polypropylene or silicon. Thefascial anchor 120 may be placed or deployed during needle placement,such as when the surgeon feels that the obturator membrane has beenpierced, or may alternatively be placed after the sling aim has beendrawn up through the thigh incision, as it can be threaded onto thesling and seated on or near the obturator membrane.

FIG. 56 illustrates the fascial anchor 120 with a serrated mesh arm 125of a sling device passing through the anchor. As will be appreciated bythose skilled in the art, the serrated mesh aim 125 may be operablycombined with a unidirectional anchor such that once the mesh aim 125 ininserted though the fascial anchor 120, the sling can only be tightenedand not loosened. Stated alternatively, the serrations on the mesh aim125 may interact with the anchor 120 such that the mesh aim 125 cannotbe pulled out in a backward direction once it has been inserted throughthe fascial anchor 120. This prevents the sling from loosening once ithas been positioned within the patient and tightened to the desired“tightness” level. Alternatively, as stated above, a bidirectionalanchor may be used that allows the sling to be loosened if it isdetermined that the sling is too tight.

As will be appreciated by those skilled in the art, when determining theoptimal position of a sling within a patient, it may be helpful for thephysician to know the amount of tension that should be placed on theano-rectum. This may be accomplished with a sling tensioning instrument,which is a device that measures pressure or deflection of the rectum inorder to determine sling tension. FIG. 57 demonstrates one exemplaryembodiment of a transrectal manometry device 128 being used to determinethe tension on the sling.

Although numerous slings have been previously illustrated and described,one common element of these slings is that they only include a centralportion that is positioned beneath, for example, the ano-rectum.However, as those skilled in the art will appreciate, slings havinganterior extension portions are also contemplated. For instance, FIG. 58illustrates a sling 130 similar to sling 16 previously described withreference to FIG. 3 that includes a pair of arms 131 and a belly orcentral portion 132 disposed therebetween. However, the sling 130further includes an anterior extension 133 that is structured toencircle the anal sphincter in order to provide additional anteriorsupport. In the exemplary embodiment shown, the anterior extension 133may be placed anterior to the anus and attached to the sling aims 131 orlateral portion of the sling central portion 132. This positioning mayconstrict the anal canal and improve anal continence.

The surgical procedures of the present invention have previously beendescribed herein with reference to a single sling. However, it should beunderstood that more than one sling may be implanted within a patientwithout departing from the intended scope of the present invention. Forinstance, FIG. 59 is a diagram illustrating the placement of two slingswithin the patient. Particularly, FIG. 59 shows both a transobturatorpost-anal sling and another sling placed anterior to the anal sphincterin the perineal body, which passes back through the ischiorectal fossaand out the buttocks.

A sling may be performed concomitantly that passes anterior to the anus(in the perineal body), and the aims of the sling may be passed eithermedial or lateral to the levator ani muscle and may either exit throughthe buttock skin, possibly passing through the gluteus maximus muscle ormay be fixed to the sacrospinous ligament using, for example, plasticanchors.

The various sling embodiments previously described and illustrated haveall been relatively narrow in width. However, as those skilled in theart will appreciate, a wider sling could be used with, for example, fouror more fixation points: two straps passing in a standard manner throughthe obturator membrane and two more straps passing posteriorly eitherthrough the gluteus maximus muscle and out through the buttocks or fixedto the sacrospinous ligament with tissue anchors or the like.

FIG. 60 illustrates one exemplary embodiment of a larger levator sling140, placed through the ischiorectal fossa, that has transobturator meshstraps 141 adjacent the obturator foramen 142 and adjustable mesh straps143 that are anchored into the sacrospinous ligament 144. As furtherillustrated in FIG. 61, these mesh straps 143 may be passed throughrings 145 with tines 146 that extend into the middle of the ring, whichare located on the proximal lateral portions of the mesh straps 143.

If anchors 147 are used in the sacrospinous ligament as illustrated inFIGS. 60-61, the anchors 147 could be attached to a strap of mesh 148which may include a stiff polypropylene rod 149 on the end. These rods149 may be placed through the rings 145 attached to the corners of theproximal mesh. As stated above, the rings 145 may have tines 146 orother devices that extend into the center of the ring and grasp themesh, so that the mesh can be tightened by pulling it through the ringsuntil the proper tension is attained.

FIG. 62 illustrates another exemplary embodiment of a larger levatorsling 150, passed through the ischiorectal fossa, that hastransobturator mesh straps 151 and proximal lateral mesh straps 152 thatare passed through the sacrospinous ligament 153 and can be adjustedbefore final closure of the skin incisions. Alternatively, the proximalmesh straps 152 could be placed through the sacrospinous ligament 153and the straps could then come out through a posterior buttock incisionand be used to adjust the tension of the sling. In this embodiment, allfour mesh straps could be used to adjust the tension on the levatorsupport.

FIGS. 63-64 illustrate an alternative embodiment of a sling inaccordance with another aspect of the present invention. Particularly,FIGS. 63-64 illustrate an exemplary sling 160 having a belly or centralportion 161 that includes a first ring 162A adjacent to a first end ofthe central portion 161 and a second ring 162B adjacent to a second endof the central portion 161. The first and second rings 162A and 162B maybe formed from any suitable material, such as a plastic.

As illustrated in FIGS. 63-64, mesh straps or arms 164 placed throughthe obturator membrane, into the ischiorectal fossa, and out through thelateral buttock incisions, may be loaded onto the rings 162A and 162B onthe lateral edges of the mesh central portion 161, and may then bepushed up to tighten the sling such that the central portion 161 isdisposed beneath the rectum 166. As illustrated in FIG. 65, which is anenlarged view of one end of the central portion 161 of the sling 160showing the second ring 162B, the rings may have a plurality of tines167 or similar devices extending into an open center thereof. As will beappreciated by those skilled in the art, when a sling aim is passedthrough the open center portion of the ring, the sling aim may engagethe tines 167.

Once the sling 160 is positioned within the patient, the belly orcentral portion 161 is advanced in an upward direction toward the rectum166 with tension placed on either sling arm 164. The first and secondrings 162A and 162B may be unidirectional devices, only permittingtightening and not loosening However, bidirectional devices are alsocontemplated. Once the sling 160 is determined to be in its finalposition, the arms 164 may be cut below the level of the rings 162A and162B (and sling central portion 161), possibly with a device that isthreaded over the sling arm and that can be advanced up into theischiorectal fossa in order to cut the arm.

Optionally, as illustrated in FIG. 64, a pair of donut-like fastenermembers 168 may be positioned adjacent the obturator membrane 169 inorder to anchor the end of the sling arms 164 that is opposite thecentral portion 161 of the sling 160.

FIG. 66 is a diagram illustrating one exemplary instrument 170 that canbe used to push the central portion 161 of the sling 160 with the firstand second lateral rings 162A and 162B up onto the sling aims 164 inorder to tighten the sling. As will be appreciated by those skilled inthe art, an end of a sling arm may be positioned through a closed loop171 in a distal end of the instrument 170. The instrument may also havea retractable blade 172 that may be operated with a blade activationbutton 173 located at a proximal end of the instrument 170. Upon pushingthe activation button 173 in the direction indicated by arrow 174, theretractable blade 172 is structured to move in the correspondingdirection indicated by arrow 175 in order to cut the sling aim after thesling has been adjusted to the desired position.

Although the present invention has been described with reference topreferred embodiments, workers skilled in the art will recognize thatchanges may be made in faun and detail without departing from the spiritand scope of the invention.

What is claimed:
 1. A system for reducing anal incontinence comprising:a sling structured to be implanted in a patient, the sling including acentral portion; at least two arms coupled to said central portion andextending laterally therefrom; and one or more sub-rectal extensionelements structured for attachment to a coccyx of the patient andcoupled to said central portion, wherein the central portion has a shapethat is wider than said at least two arms and which, after implantation,is structured to conform to the external contour of the anus, rectum,ano-rectal angle and/or levator ani muscles in said patient.
 2. Thesystem of claim 1 further including an introducer needle having a needletip and a needle shaft, said introducer needle attachable to said armsfor positioning said arms through an obturator formen.
 3. The system ofclaim 2 wherein said introducer needle further comprises a hollow sheathcovering said introducer needle.
 4. The system of claim 2 wherein saidneedle tip is threadably removable from said needle shaft.
 5. The systemof claim 4 further including a male-connector screw having a threadedend and a non-threaded end, said non-threaded end coupled to said arms.6. The system of claim 5 wherein said male-connector screw is structuredto threadably couple to said needle shaft upon removal of said needletip.
 7. The system of claim 2 wherein said needle tip comprises a jawfor grasping said arms.
 8. The system of claim 3 wherein said armsfurther include a suture coupled thereto.
 9. The system of claim 8wherein said sheath includes a spring-mechanism for deploying the needletip.
 10. The system of claim 8 or 9 wherein said needle tip includes anotch for operably coupling to said suture.
 11. The system of claim 1wherein the central portion includes an adjustably inflatable sac. 12.The system of claim 11 wherein said adjustably inflatable sac furtherincludes a subcutaneously accessible port positioned at a bottom of thecentral portion for the introduction and removal of fluid.
 13. Thesystem of claim 11 wherein said adjustably inflatable sac furtherincludes connector tubing having first and second ends, said connectortubing coupled to said sac at said first end and having a port coupledthereto at said second end for introducing fluid into and removing fluidfrom said sac.
 14. The system of claim 1 wherein said arms includeserrations thereon for maintaining said sling in position afterimplantation.
 15. The system of claim 1 further comprising fixationdevices for attaching said arms to pelvic bone, said fixation devicesselected from the group consisting of bone anchors, suture material andcombinations thereof.
 16. The system of claim 1 wherein said one or moresub-rectal extension elements comprise rigid, semi-rigid or flexibleelements coupled to said central portion in a direction transverse tothe length of the sling.
 17. The system of claim 1 further comprising ameasuring device for measuring the angle made between the anus andrectum, said measuring device having a proximal ring and a distal ringoperably connected by joint wherein said angle is displayed on a visualscale coupled to said proximal ring.
 18. The system of claim 17 whereinsaid measuring device is structured to fit over a finger.
 19. The systemof claim 1 wherein each arm includes a removable sheath for facilitatingpassage through an obturator foramen.
 20. The system of claim 1 whereinthe sling comprises a material selected from the group consisting of asynthetic material, a natural xenograft material, an allograft materialand combinations thereof.
 21. The system of claim 19 wherein each arm ofthe sling is made from elastic material.
 22. The system of claim 1further comprising a first connector coupled to an end of a first one ofsaid at least two arms, said first connector comprising a firstring-shaped member; and a second connector coupled to an end of a secondone of said at least two arms, said second connector comprising a secondring-shaped member.
 23. The system of claim 1 further comprising anadjustable device coupled to the inferior surface of the centralportion, the adjustable device including a housing and adjustment meansfor adjusting a tension of the first and second sling arms; saidadjustment means coupled to said housing, wherein rotating theadjustment means in a first direction increases the tension of the firstand second sling arms, and wherein rotating the adjustment means in asecond, opposite direction decreases the tension of the first and secondsling arms.
 24. The system of claim 22, wherein the first sling arm isinsertable though an open center of the first ring-shaped member, andwherein the second sling arm is insertable though an open center of thesecond ring-shaped member.
 25. The system of claim 24, wherein the firstand second ring-shaped members each include a plurality of tinesextending toward the open center of the ring-shaped members.
 26. Thesystem of claim 1, wherein said at least two anus are formed from a meshmaterial.
 27. The system of claim 1, wherein the first and second slinganus each include a serrated portion.
 28. The system of claim 22,wherein the first and second connectors are unidirectional devices thatallow tightening of the first and second sling arms.
 29. The sling ofclaim 22, wherein the first and second connectors are bidirectionaldevices that allow both tightening and loosening of the first and secondsling arms.
 30. The system of claim 1 wherein said central portioncomprises a preformed curved shape.
 31. The system of claim 1 whereinsaid sub-rectal portion includes an extension coupled to an inferiorportion thereof, said extension structured to be fixed to the coccyx.32. The system of claim 1 wherein said sub-rectal portion includes aposterior aspect that is structured to be coupled to the coccyx.